Sec. 604. ANIMAL RULE REPORT
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## SEC. 604 ANIMAL RULE REPORT ###
(a)Study The Comptroller General of the United States shall conduct a study on the application of the requirements under subsections
(c)and
(d)of section 565 of the of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb-4) (referred to in this section as the “animal rule”) as a component of medical countermeasure advanced development under the Biomedical Advanced Research and Development Authority and regulatory review by the Food and Drug Administration. In conducting such study, the Comptroller General shall examine the following: ####
(1)The extent to which advanced development and review of a medical countermeasure are coordinated between the Biomedical Advanced Research and Development Authority and the Food and Drug Administration, including activities that facilitate appropriate and efficient design of studies to support approval, licensure, and authorization under the animal rule, consistent with the recommendations in the animal rule guidance, issued pursuant to section 565(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb-4(c)) and entitled “Product Development Under the Animal Rule: Guidance for Industry” (issued in October 2015), to resolve discrepancies in the design of adequate and well-controlled efficacy studies conducted in animal models related to the provision of substantial evidence of effectiveness for the product approved, licensed, or authorized under the animal rule. ####
(2)The consistency of the application of the animal rule among and between review divisions within the Food and Drug Administration. ####
(3)The flexibility pursuant to the animal rule to address variations in countermeasure development and review processes, including the extent to which qualified animal models are adopted and used within the Food and Drug Administration in regulatory decisionmaking with respect to medical countermeasures. ####
(4)The extent to which the guidance issued under section 565(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb-4(c)), entitled, “Product Development Under the Animal Rule: Guidance for Industry” (issued in October 2015), has assisted in achieving the purposes described in paragraphs (1), (2), and (3). ###
(b)Consultations In conducting the study under subsection (a), the Comptroller General of the United States shall consult with— ####
(1)the Federal agencies responsible for advancing, reviewing, and procuring medical countermeasures, including the Office of the Assistant Secretary for Preparedness and Response, the Biomedical Advanced Research and Development Authority, the Food and Drug Administration, and the Department of Defense; ####
(2)manufacturers involved in the research and development of medical countermeasures to address biological, chemical, radiological, or nuclear threats; and ####
(3)other biodefense stakeholders, as applicable. ###
(c)Report Not later than 3 years after the date of enactment of this Act, the Comptroller General of the United States shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report containing the results of the study conducted under subsection
(a)and recommendations to improve the application and consistency of the requirements under subsections
(c)and
(d)of section 565 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb-4) to support and expedite the research and development of medical countermeasures, as applicable. ###
(d)Protection of National Security The Comptroller General of the United States shall conduct the study and issue the assessment and report under this section in a manner that does not compromise national security.
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Sec. 604
ANIMAL RULE REPORT
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